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14C-SB649868
14C-SB649868 is a Dual orexin receptor antagonist Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 1 development.
Blocks both orexin-1 and orexin-2 receptors, inhibiting the wake-promoting effects of orexin neuropeptides in the brain.
14C-SB649868 is a small molecule used in a radiolabel study to determine its excretion, balance, and pharmacokinetics in healthy volunteers. It is being investigated for the treatment of Sleep Initiation and Maintenance Disorders.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | 14C-SB649868 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Dual orexin receptor antagonist |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
SB649868 is a dual orexin receptor antagonist that blocks the binding of orexin-A and orexin-B neuropeptides to their receptors. By inhibiting orexin signaling, which promotes wakefulness and arousal, the compound was investigated for its potential to treat insomnia and sleep disorders.
Approved indications
Common side effects
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 14C-SB649868 CI brief — competitive landscape report
- 14C-SB649868 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about 14C-SB649868
What is 14C-SB649868?
How does 14C-SB649868 work?
Who makes 14C-SB649868?
What drug class is 14C-SB649868 in?
What development phase is 14C-SB649868 in?
Related
- Drug class: All Dual orexin receptor antagonist drugs
- Manufacturer: GlaxoSmithKline — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing